510(k) · Cleared
ClearedHF54 Combination Ultrasound Interferential and Premodulated Stimulation System with Optional Hands-Free Operation, Model
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill Laboratories Co. · PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Cleared on Mar 12, 2008 as substantially equivalent to K062256 (Hill Laboratories Co., 2007) after a 212-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Mar 12, 2008
- Review
- 212 days
- Class
- Class II
- Product code
- PFW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001179 (2000). 9 ancestors in all, the oldest K941461 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 3 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 2 generations backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- 1 generation backK062256 HF54 Combination Ultrasound Interferential and Premodulated…Hill Laboratories Co. · 2007
- This deviceK072256 HF54 Combination Ultrasound Interferential and Premodulated…Hill Laboratories Co. · 2008
- Descendant · cites it directly · 0 of its ownK090250 Electro-Light TherapyHill Laboratories Co. · 2010
Most influential descendants
Showing 1 of 1 · See all- K090250Electro-Light TherapyHill Laboratories Co. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −3 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −2 | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| −1 | K062256 | HF54 Combination Ultrasound Interferential and Premodulated Stimulation System | Hill Laboratories Co. | 2007 | — |
| 0 (this device) | K072256 | HF54 Combination Ultrasound Interferential and Premodulated Stimulation System… | Hill Laboratories Co. | 2008 | — |
| +1 | K090250 | Electro-Light Therapy | Hill Laboratories Co. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PFW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PFW device
- #1 K260076 SAM 3.0 Multi-Hour Continuous Ultrasound Devicescore 12.1 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062256 | HF54 Combination Ultrasound Interferential and Premodulated Stimulation SystemSummary page 3…2: Particular requirements for the safety of nerve and muscle stimulators 12. Predicate Devices 510(k) Number Trade or Proprietary or Model Name Manufacturer Class K062256 HF 54 Hill Laboratories 2 HF54 With Optional Hands-free operation December 10, 2007 Page 19 of 70 12.1 12.1.1… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090250 | Electro-Light Therapy | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K090250 (Hill Laboratories Co., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PFW devicesPFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · PFW
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PFW
Too few PFW 510(k)s in any year since 2007 to give a median.
Recalls per year · PFW
No recall names PFW since 2007.
Adverse event reports per year · PFW
No MAUDE report names PFW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The HF54 interferential therapy and premodulated therapy is indicated for: Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain. Ultrasound therapy is available from the HF54 and indicated for: Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as: Relief of pain joint contractures This can be done using One or two…
Read the full statement (222 words)
The HF54 interferential therapy and premodulated therapy is indicated for:
Pain relief for:
Symptomatic relief of chronic intractable pain and/or
management of traumatic or post surgical pain.
Ultrasound therapy is available from the HF54 and indicated for:
Applying therapeutic deep heat within body tissues for the treatment of
selected chronic and sub-chronic medical conditions such as:
Relief of pain
joint contractures
This can be done using One or two ultrasound applicators. The second
ultrasound applicator is optional.
Ultrasound therapy, either alone or in combination with interferential
therapy or premodulated therapy can be used in a scanned manner (where
the therapist moves the applicator) or for specific treatment areas
identified in the operator’s manual, the applicator can be used in a hands-
free manner (where the applicator remains stationary).
An Infrared Therapy Probe is available as an optional accessory (HF023)
for use with the Hill Laboratories HF54 Combination Ultrasound
Interferential and premodulated stimulation system or for stand-alone use
with an optional external medical grade, isolated power supply. It is used
to provide topical heating for:
* Temporary increases in local blood flow and circulation
* Temporary relief of minor muscle and joint aches
» Temporary relief of pain and stiffness
* Relaxation of muscles
¢ Temporary relief (or relaxation) of muscle spasms
¢ Temporary relief of minor pain and stiffness associated with
arthritis
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K072256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072256: HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with Optional Hands-Free Operation, Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072256
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026